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High-Yield HIV Testing, Facilitated Linkage to Care, and Prevention for Female Youth in Kenya (GIRLS Study): Implementation Science Protocol for a Priority Population

Inwani, Irene; Chhun, Nok; Agot, Kawango; Cleland, Charles M; Buttolph, Jasmine; Thirumurthy, Harsha; Kurth, Ann E
BACKGROUND:Sub-Saharan Africa is the region with the highest HIV burden. Adolescent girls and young women (AGYW) in the age range of 15 to 24 years are twice as likely as their male peers to be infected, making females in sub-Saharan Africa the most at-risk group for HIV infection. It is therefore critical to prioritize access to HIV testing, prevention, and treatment for this vulnerable population. OBJECTIVE:Using an implementation science framework, the purpose of this research protocol was to describe the approaches we propose to optimize engagement of AGYW in both the HIV prevention and care continuum and to determine the recruitment and testing strategies that identify the highest proportion of previously undiagnosed HIV infections. METHODS:We will compare two seek recruitment strategies, three test strategies, and pilot adaptive linkage to care interventions (sequential multiple assignment randomized trial [SMART] design) among AGYW in the age range of 15 to 24 years in Homa Bay County, western Kenya. AGYW will be recruited in the home or community-based setting and offered three testing options: oral fluid HIV self-testing, staff-aided rapid HIV testing, or referral to a health care facility for standard HIV testing services. Newly diagnosed AGYW with HIV will be enrolled in the SMART trial pilot to determine the most effective way to support initial linkage to care after a positive diagnosis. They will be randomized to standard referral (counseling and a referral note) or standard referral plus SMS text message (short message service, SMS); those not linked to care within 2 weeks will be rerandomized to receive an additional SMS text message or a one-time financial incentive (approximately US $4). We will also evaluate a primary prevention messaging intervention to support identified high-risk HIV-negative AGYW to reduce their HIV risk and adhere to HIV retesting recommendations. We will also conduct analyses to determine the incremental cost-effectiveness of the seek, testing and linkage interventions. RESULTS:We expect to enroll 1200 participants overall, with a random selection of 100 high-risk HIV-negative AGYW for the SMS prevention intervention (HIV-negative cohort) and approximately 108 AGYW who are living with HIV for the SMART design pilot of adaptive linkage to care interventions (HIV-positive cohort). We anticipate that the linkage to care interventions will be feasible and acceptable to implement. Lastly, the use of SMS text messages to engage participants will provide pilot data to the Kenyan government currently exploring a national platform to track and support linkage, adherence to treatment, retention, and prevention interventions for improved outcomes. CONCLUSIONS:Lessons learned will inform best approaches to identify new HIV diagnoses to increase AGYW's uptake of HIV prevention, testing, and linkage to care services in a high HIV-burden African setting. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov NCT02735642; https://clinicaltrials.gov/ct2/show/NCT02735642 (Archived by WebCite at http://www.webcitation.org/6vgLLHLC9).
PMCID:5754209
PMID: 29237583
ISSN: 1929-0748
CID: 2843512

Syndemic Risk Classes and Substance Use Problems among Adults in High-Risk Urban Areas: A Latent Class Analysis

Cleland, Charles M; Lanza, Stephanie T; Vasilenko, Sara A; Gwadz, Marya
Substance use problems tend to co-occur with risk factors that are especially prevalent in urban communities with high rates of poverty. The present study draws on Syndemics Theory to understand profiles of risk and resilience and their associations with substance use problems in a population at risk for adverse outcomes. African-American/Black and Hispanic heterosexual adults (N = 2,853) were recruited by respondent-driven sampling from an urban area with elevated poverty rates, and completed a structured assessment battery covering sociodemographics, syndemic factors (that is, multiple, co-occurring risk factors), and substance use. More than one-third of participants (36%) met criteria for either an alcohol or a drug problem in the past year. Latent class analysis identified profiles of risk and resilience, separately for women and men, which were associated with the probability of a substance use problem. Almost a third of women (27%) and 38% of men had lower risk profiles-patterns of resilience not apparent in other types of analyses. Profiles with more risk and fewer resilience factors were associated with an increased probability of substance use problems, but profiles with fewer risk and more resilience factors had rates of substance use problems that were very similar to the general adult population. Relative to the lowest risk profile, profiles with the most risk and fewest resilience factors were associated with increased odds of a substance use problem for both women [adjusted odds ratio (aOR) = 8.50; 95% CI: 3.85-18.74] and men (aOR = 11.68; 95% CI: 6.91-19.74). Addressing syndemic factors in substance use treatment and prevention may yield improved outcomes.
PMCID:5594078
PMID: 28936431
ISSN: 2296-2565
CID: 2707782

Hair testing to assess both known and unknown use of drugs amongst ecstasy users in the electronic dance music scene

Palamar, Joseph J; Salomone, Alberto; Gerace, Enrico; Di Corcia, Daniele; Vincenti, Marco; Cleland, Charles M
BACKGROUND: Data on both known and unknown drug use in the electronic dance music (EDM) scene is important to inform prevention and harm reduction. While surveys are the most common method of querying drug use, additional biological data can help validate use and detect unknown/unintentional use of drugs such as new psychoactive substances (NPS). We sought to determine the extent of both known and unknown use of various substances in this high-risk scene. METHODS: We hair-tested 90 self-reported past-year ecstasy/MDMA/Molly users attending EDM parties in New York City during the summer of 2016 using UHPLC-MS/MS. Results were compared to self-reported past-year use. RESULTS: Three quarters (74.4%) tested positive for MDMA, a third (33.3%) tested positive for an NPS, and 27.8% tested positive specifically for one or more synthetic cathinones (e.g., butylone, ethylone, pentylone, methylone, alpha-PVP). Half (51.1%) of participants tested positive for a drug not self-reported, with most testing positive for synthetic cathinones (72.0%), methamphetamine (69.0%), other NPS stimulants (e.g., 4-FA, 5/6-APB; 66.7%), or new dissociatives (e.g., methoxetamine, diphenidine; 60.0%). Attending parties every other week or more often, reporting higher-frequency ecstasy pill use, having tested one's ecstasy, and having found out one's ecstasy was adulterated, were risk factors for testing positive for synthetic cathinones and NPS in general. CONCLUSION: Hair testing appears to be a valuable addition to drug epidemiology studies. Many EDM party attendees-even those who test their ecstasy-are unknowingly using NPS and/or other drugs. Prevention information and harm reduction may help reduce unknown/unintentional use.
PMCID:5601020
PMID: 28810159
ISSN: 1873-4758
CID: 2670792

Health Technology-Enabled Interventions for Adherence Support and Retention in Care Among US HIV-Infected Adolescents and Young Adults: An Integrative Review

Navarra, Ann-Margaret Dunn; Gwadz, Marya Viorst; Whittemore, Robin; Bakken, Suzanne R; Cleland, Charles M; Burleson, Winslow; Jacobs, Susan Kaplan; Melkus, Gail D'Eramo
The objective of this integrative review was to describe current US trends for health technology-enabled adherence interventions among behaviorally HIV-infected youth (ages 13-29 years), and present the feasibility and efficacy of identified interventions. A comprehensive search was executed across five electronic databases (January 2005-March 2016). Of the 1911 identified studies, nine met the inclusion criteria of quantitative or mixed methods design, technology-enabled adherence and or retention intervention for US HIV-infected youth. The majority were small pilots. Intervention dose varied between studies applying similar technology platforms with more than half not informed by a theoretical framework. Retention in care was not a reported outcome, and operationalization of adherence was heterogeneous across studies. Despite these limitations, synthesized findings from this review demonstrate feasibility of computer-based interventions, and initial efficacy of SMS texting for adherence support among HIV-infected youth. Moving forward, there is a pressing need for the expansion of this evidence base.
PMCID:5731637
PMID: 28776275
ISSN: 1573-3254
CID: 2655982

Staff Perspectives on a Tablet-Based Intervention to Increase HIV Testing in a High Volume, Urban Emergency Department

Aronson, Ian David; Guarino, Honoria; Bennett, Alexander S; Marsch, Lisa A; Gwadz, Marya; Cleland, Charles M; Damschroder, Laura; Bania, Theodore C
Emergency departments (EDs) frequently serve people who have limited, if any, additional interactions with health care, yet many ED patients are not offered HIV testing, and those who are frequently decline. ED staff (n = 13) at a high volume urban ED (technicians, nurses, physicians, and administrators) were interviewed to elicit their perspectives on the feasibility and acceptability of a tablet-based intervention designed to increase HIV test rates among patients who initially decline testing. Content-based thematic analysis of semi-structured interviews indicated overall support for interventions to increase HIV testing, but a lack of available staff resources emerged as a potential barrier to widespread implementation. Also, some ED staff questioned whether it was appropriate to shift responsibility for public health services, such as HIV testing, to the ED instead of a primary care setting. Although tablet-based interventions have been shown effective in high volume ED settings and can potentially increase HIV test rates among hard-to-reach populations, additional effort is now required to better integrate this type of intervention into existing workflows.
PMCID:5504145
PMID: 28744454
ISSN: 2296-2565
CID: 2647922

Racial & Ethnic Disparities in Predictors of Glycemia: A Moderated Mediation Analysis of Inflammation-Related Predictors of Diabetes in the NHANES 2007-2010 [Meeting Abstract]

Nowlin, Sarah; Cleland, Charles; Parekh, Niyati; Hagan, Holly; Melkus, Gail D'Eramo
ISI:000395805700003
ISSN: 1538-9847
CID: 2641642

It's a Process: Reactions to HIV Diagnosis and Engagement in HIV Care among High-Risk Heterosexuals

Kutnick, Alexandra H; Gwadz, Marya Viorst; Cleland, Charles M; Leonard, Noelle R; Freeman, Robert; Ritchie, Amanda S; McCright-Gill, Talaya; Ha, Kathy; Martinez, Belkis Y
After HIV diagnosis, heterosexuals in high-poverty urban areas evidence delays in linkage to care and antiretroviral therapy initiation compared to other groups. Yet barriers to/facilitators of HIV care among these high-risk heterosexuals are understudied. Under the theory of triadic influence, putative barriers to HIV care engagement include individual/attitudinal-level (e.g., fear, medical distrust), social-level (e.g., stigma), and structural-level influences (e.g., poor access). Participants were African-American/Black and Hispanic adults found newly diagnosed with HIV (N = 25) as part of a community-based HIV testing study with heterosexuals in a high-poverty, high-HIV-incidence urban area. A sequential explanatory mixed-methods design was used. We described linkage to HIV care and clinical outcomes [CD4 counts, viral load (VL) levels] over 1 year, and then addressed qualitative research questions about the experience of receiving a new HIV diagnosis, its effects on timely engagement in HIV care, and other barriers and facilitators. Participants were assessed five times, receiving a structured interview battery, laboratory tests, data extraction from the medical record, a post-test counseling session, and in-person/phone contacts to foster linkage to care. Participants were randomly selected for qualitative interviews (N = 15/25) that were recorded and transcribed, then analyzed using systematic content analysis. Participants were 50 years old, on average (SD = 7.2 years), mostly male (80%), primarily African-American/Black (88%), and low socioeconomic status. At the first follow-up, rates of engagement in care were high (78%), but viral suppression was modest (39%). Rates improved by the final follow-up (96% engaged, 62% virally suppressed). Two-thirds (69%) were adequately retained in care over 1 year. Qualitative results revealed multi-faceted responses to receiving an HIV diagnosis. Problems accepting and internalizing one's HIV status were common. Reaching acceptance of one's HIV-infected status was frequently a protracted and circuitous process, but acceptance is vital for engagement in HIV care. Fear of stigma and loss of important relationships were potent barriers to acceptance. Thus, partially as a result of difficulties accepting HIV status, delays in achieving an undetectable VL are common in this population, with serious potential negative consequences for individual and public health. Interventions to foster acceptance of HIV status are needed.
PMCID:5423945
PMID: 28540287
ISSN: 2296-2565
CID: 2575822

Eliminating Racial/Ethnic Disparities in AIDS Clinical Trials in the United States: A Qualitative Exploration of an Efficacious Social/Behavioral Intervention

Ritchie, Amanda; Gwadz, Marya Viorst; Perlman, David; De Guzman, Rebecca; Leonard, Noelle R; Cleland, Charles M
BACKGROUND: African American/Black and Hispanic persons living with HIV (AABH-PLWH) are under-represented in AIDS clinical trials (ACTs) in the United States. Barriers AABH-PLWH experience to ACTs are multi-faceted, including distrust of medical research, low levels of knowledge, unsupportive social norms, lack of referral, and challenges navigating ACT systems. In past research we found a multi-component peer-driven intervention was efficacious in boosting rates of screening for/enrollment into ACTs. The present qualitative study seeks to understand AABH-PLWH's perspectives on which specific intervention features or components had utility. Interventions features explored included structural elements (e.g., small group sessions, individual sessions on the ACT research unit); approaches (e.g., Motivational Interviewing); and specific components (e.g., small-group discussion of historical and cultural factors reducing participation among AABH-PLWH). METHODS: A total of 37 AABH-PLWH (mean age 50.6 years, SD=7.5 years; 48.6% female; 62.2% African American/Black, 27.0% Hispanic) were purposively selected from a larger study for in-depth interviews, which were audio-recorded, transcribed verbatim, and analyzed using systematic content analysis. RESULTS: We found the intervention improved knowledge and positive attitudes toward ACTs, and triggered social-level facilitators such as altruism and more positive social norms. Discussions of cultural/historical barriers to ACTs associated with race/ethnicity had utility. Holding a session on the ACT research unit reduced fear and increased motivation. Results highlighted the value of Motivational Interviewing, and several components were perceived as less useful (e.g., involving social network members in ACT decisions). CONCLUSION: Findings can inform future intervention designs to address racial/ethnic disparities in ACTs and have implications for trials of other conditions where racial/ethnic disparities persist.
PMCID:5431576
PMID: 28515963
ISSN: 2155-6113
CID: 2562462

Assessing self-reported use of new psychoactive substances: The impact of gate questions

Palamar, Joseph J; Acosta, Patricia; Calderon, Fermin Fernandez; Sherman, Scott; Cleland, Charles M
BACKGROUND: New psychoactive substances (NPS) continue to emerge; however, few surveys of substance use ask about NPS use. Research is needed to determine how to most effectively query use of NPS and other uncommon drugs. OBJECTIVE: To determine whether prevalence of self-reported lifetime and past-year use differs depending on whether or not queries about NPS use are preceded by "gate questions." Gate questions utilize skip-logic, such that only a "yes" response to the use of specific drug class is followed by more extensive queries of drug use in that drug class. METHODS: We surveyed 1,048 nightclub and dance festival attendees (42.6% female) entering randomly selected venues in New York City in 2016. Participants were randomized to gate vs. no gate question before each drug category. Analyses focus on eight categories classifying 145 compounds: NBOMe, 2C, DOx, "bath salts" (synthetic cathinones), other stimulants, tryptamines, dissociatives, and non-phenethylamine psychedelics. Participants, however, were asked about specific "bath salts" regardless of their response to the gate question to test reliability. We examined whether prevalence of use of each category differed by gate condition and whether gate effects were moderated by participant demographics. RESULTS: Prevalence of use of DOx, other stimulants, and non-phenethylamine psychedelics was higher without a gate question. Gate effects for other stimulants and non-phenethylamine psychedelics were larger among white participants and those attending parties less frequently. Almost one in ten (9.3%) participants reporting no "bath salt" use via the gate question later reported use of a "bath salt" such as mephedrone, methedrone, or methylone. CONCLUSION: Omitting gate questions may improve accuracy of data collected via self-report.
PMCID:5660869
PMID: 28485987
ISSN: 1097-9891
CID: 2548942

Using the multiphase optimization strategy (MOST) to optimize an HIV care continuum intervention for vulnerable populations: a study protocol

Gwadz, Marya Viorst; Collins, Linda M; Cleland, Charles M; Leonard, Noelle R; Wilton, Leo; Gandhi, Monica; Scott Braithwaite, R; Perlman, David C; Kutnick, Alexandra; Ritchie, Amanda S
BACKGROUND: More than half of persons living with HIV (PLWH) in the United States are insufficiently engaged in HIV primary care and not taking antiretroviral therapy (ART), mainly African Americans/Blacks and Hispanics. In the proposed project, a potent and innovative research methodology, the multiphase optimization strategy (MOST), will be employed to develop a highly efficacious, efficient, scalable, and cost-effective intervention to increase engagement along the HIV care continuum. Whereas randomized controlled trials are valuable for evaluating the efficacy of multi-component interventions as a package, they are not designed to evaluate which specific components contribute to efficacy. MOST, a pioneering, engineering-inspired framework, addresses this problem through highly efficient randomized experimentation to assess the performance of individual intervention components and their interactions. We propose to use MOST to engineer an intervention to increase engagement along the HIV care continuum for African American/Black and Hispanic PLWH not well engaged in care and not taking ART. Further, the intervention will be optimized for cost-effectiveness. A similar set of multi-level factors impede both HIV care and ART initiation for African American/Black and Hispanic PLWH, primary among them individual- (e.g., substance use, distrust, fear), social- (e.g., stigma), and structural-level barriers (e.g., difficulties accessing ancillary services). Guided by a multi-level social cognitive theory, and using the motivational interviewing approach, the study will evaluate five distinct culturally based intervention components (i.e., counseling sessions, pre-adherence preparation, support groups, peer mentorship, and patient navigation), each designed to address a specific barrier to HIV care and ART initiation. These components are well-grounded in the empirical literature and were found acceptable, feasible, and promising with respect to efficacy in a preliminary study. METHODS/DESIGN: Study aims are: 1) using a highly efficient fractional factorial experimental design, identify which of five intervention components contribute meaningfully to improvement in HIV viral suppression, and secondary outcomes of ART adherence and engagement in HIV primary care; 2) identify mediators and moderators of intervention component efficacy; and 3) using a mathematical modeling approach, build the most cost-effective and efficient intervention package from the efficacious components. A heterogeneous sample of African American/Black and Hispanic PLWH (with respect to age, substance use, and sexual minority status) will be recruited with a proven hybrid sampling method using targeted sampling in community settings and peer recruitment (N = 512). DISCUSSION: This is the first study to apply the MOST framework in the field of HIV prevention and treatment. This innovative study will produce a culturally based HIV care continuum intervention for the nation's most vulnerable PLWH, optimized for cost-effectiveness, and with exceptional levels of efficacy, efficiency, and scalability. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02801747 , Registered June 8, 2016.
PMCID:5418718
PMID: 28472928
ISSN: 1471-2458
CID: 2546692